Chronic Rhinosinusitis Treatment Study

Clinical Trial Title

Study evaluating the efficacy and safety of intranasal administration of OPN-375 in subjects with chronic sinusitis with or without the presence of nasal polyps.

National Clinical Trial Number:

NCT03781804

Clinical Trial Protocol Description:

A 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 and 372 μg of OPN-375 twice a day (BID) in subjects with chronic sinusitis with or without the presence of nasal polyps.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are a man or woman18 years of age or older at baseline visit.
  • Women of child bearing potential must be abstinent, or if sexually active, be practicing an effective method of birth control before entry and throughout the study, or be surgically sterile, or be postmenopausal (amenorrhea for at least 1 year).
  • Women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Screening).
  • Have a history of chronic sinusitis and be currently experiencing 2 or more of the following symptoms, 1 of which has to be either nasal congestion or nasal discharge (anterior and/or posterior nasal discharge) for equal to or greater than 12 weeks:
    • Nasal congestion
    • Nasal discharge (anterior and/or posterior nasal discharge)
    • Facial pain or pressure
    • Reduction or loss of smell

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Pete Batra, MD

Contact Information

Mahendra Shah